The invention relates generally to medical fluid flow connectors having valves, and more particularly to self-sealing, needle-free, male connectors.
Male and female medical fluid connectors are used in a variety of medical applications. One common application is where there is a desire to interconnect a medical device with tubing material that forms a part of a patient's intravenous (“IV”) medical fluid administration set. Such administration sets typically include one or more female connectors into which may be inserted a male connector to establish fluid communication. The female connectors typically include an internal valve that is activated, or opened, by insertion of the male connector into the female connector. Once the internal valve is open, fluid may flow through both the female and male connectors in either direction. The most common types of IV fluid exchanges use a syringe fitted with a nozzle that is designed to be received into a female connector attached to the patient's IV set. The syringe may be used to infuse fluid into the patient's circulatory system or to withdraw fluid from the patient.
In the example discussed above, a common connector used for such purposes includes a Luer portion. Such connectors are well known as needle-free connectors in that no sharp objects such as sharpened needles are used for fluid conduction. In the case of female Luer connectors, a cavity is provided having a wall that tapers inward toward the center of the connector according to the generally accepted ISO Luer specification. In the case of male connectors, the male connector, or nozzle, has a taper that is complementary to the female connector taper and also meets the ISO Luer specification. The male connector is frusto-conical in general appearance.
Connectors having an integral valve that defaults to a closed position; i.e. position that prohibits fluid flow, are also known as self-sealing connectors. The integral valve may also be called a “seal”. The self-sealing, needle-free connectors presently known and used in the art are generally designed to be connected to a patient's IV line, drug, or solution source, or other medical device such that the connector's seal operates to trap all fluid on the side of the connector toward the patient or other device. Such connectors are female. The typical male connector on the other hand is unsealed.
In use, the syringe or other device is often configured with a male Luer connector so as to engage the female Luer connector of the self-sealing female connector and cause the male Luer's central boss to contact the female Luer's seal membrane, opening the slit formed in the membrane and creating a fluid path through the connector. See U.S. Pat. No. 5,676,346 to Leinsing, incorporated herein by reference, for an example of a connector having a female Luer connector and an integral valve. After the necessary fluids have been dispensed or withdrawn, the syringe is removed and the slit in the needle-free connector's seal membrane closes to reseal the connector and trap all bodily fluids, including any just-dispensed medications, on the patient side of the connector.
This prevents any escape of the fluids and protects both the patient and the care giver from possible dangerous contamination. However, the free end of the syringe and any residual fluids remaining therein are unsealed and exposed. In the case of chemotherapy, some of the chemical reagents that are used are toxic and the care giver should avoid contact with them. It is more difficult to do so when the male connector is not sealed. Drops can inadvertently escape from the male connector and dwell on a flat surface where they may come into contact with the skin of a care giver, or may fall directly from the male connector to the care giver's skin. Both situations are highly undesirable.
In another case; i.e., in the area of nuclear medicine where radioactive isotopes are administered to patients, it is critical that inadvertent exposure to the isotopes be minimized for the safety of both the care giver and the patient. Such unstable elements should be carefully guarded from undesirable contact with the care giver. Yet, with the existing connectors known and used in the art, the isotope may be sealed off while still in its vial prior to administration, and may be sealed off on the patient side of the typical self-sealing female needle-free connector after administration, as discussed above, but the syringe or other device used to transfer the isotope from its container to the patient during administration is unsealed and could allow undesired exposure to the isotope.
While the self-sealing, needle-free, female Luer connectors have provided a significant advance in the art, and generally serve their intended purpose of providing a sealed, needle-free connection that remains on a patient interface or the like and allows for the connection of a syringe or other such device to dispense or extract fluids, it would be an improvement in the art if male connectors were available that also seal so that certain fluids were not allowed on exterior surfaces of syringes or other devices. Such sealed male connectors would better control exposure to fluids.
Some sealed male needle-free connectors have been known in the art; however, in some cases, numerous parts with relatively small tolerances make such connectors difficult to manufacture at a lower cost. It remains a goal of medical device manufacturers to produce high quality medical components at the lowest cost possible so that health care may reach as many people as possible.
Hence a need has been recognized by those skilled in the art for a male connector having a valve or seal that prevents leakage of fluid from the connector and during disconnection of the male connector from another connector. A need has also been recognized for a needle-free, male Luer connector that seals the male Luer connector in a male-female connection so that users of the connector are protected from hazardous drugs that remain on the Luer tip surface when disengaged. A further need has been recognized for a male connector with an integral valve that can be more easily manufactured at lower cost. The present invention fulfills these needs and others.